Abstract
Background: Reducing the rates of Sexually Transmitted Infections (STIs) amongst young people is a public health priority. The best way to avoid STIs from penetrative sex is to use a condom but young people report inconsistent use. A missed opportunity to intervene to increase condom use is when young people access self-sampling kits for STIs via the internet. The potential of this opportunity is enhanced by the increasing numbers of young people being tested via this route every year in England. Hence, in a co-creation by young people, stakeholders and researchers, Wrapped was developed: a fully automated, multi-component and interactive digital behaviour change intervention developed for users of STI self-sampling websites aged 16-24 years.
Objective: The present paper is a protocol for a feasibility randomised controlled trial (fRCT). The fRCT seeks to establish whether it is feasible to run an RCT to test the effectiveness and cost-effectiveness of Wrapped. Wrapped aims to reduce the incidence of STIs through increasing correct and consistent condom use amongst users of STI self-sampling websites aged 16-24 years old.
Methods: A two-arm parallel group randomised fRCT of Wrapped plus usual care, compared to usual care only (basic information on STIs and condom use), with a nested qualitative study. A minimum of 230 participants (aged 16-24 years) are recruited from an existing chlamydia self-sampling website. Participants are randomised into one of two parallel groups (1:1 allocation). Primary outcomes are the percentage of users recruited to the fRCT and the percentage of randomised participants that return a chlamydia self-sampling kit at month (M) 12. Additionally, besides chlamydia positivity based on biological samples, surveys at baseline (M0), M3, M6 and M12, are used to assess condom use attitude, behavioural capability, self-efficacy, and intention, along with details of any partnered sexual activity and condom use, and health economic data. Nested qualitative interviews with trial participants are used to gain insight into factors affecting recruitment and attrition.
Results: Recruitment to the fRCT began in March 2021 and was completed in October 2021. Data collection is likely to be completed by the end of December 2022.
Conclusions: This feasibility study will provide data to inform the design of a future definitive trial. This work is timely given the rapid rise in the use of internet testing for STIs and the sustained high levels of STIs amongst young people.
Trial Registration: ISRCTN Registry ISRCTN17478654; http://www.isrctn.com/ISRCTN17478654
Objective: The present paper is a protocol for a feasibility randomised controlled trial (fRCT). The fRCT seeks to establish whether it is feasible to run an RCT to test the effectiveness and cost-effectiveness of Wrapped. Wrapped aims to reduce the incidence of STIs through increasing correct and consistent condom use amongst users of STI self-sampling websites aged 16-24 years old.
Methods: A two-arm parallel group randomised fRCT of Wrapped plus usual care, compared to usual care only (basic information on STIs and condom use), with a nested qualitative study. A minimum of 230 participants (aged 16-24 years) are recruited from an existing chlamydia self-sampling website. Participants are randomised into one of two parallel groups (1:1 allocation). Primary outcomes are the percentage of users recruited to the fRCT and the percentage of randomised participants that return a chlamydia self-sampling kit at month (M) 12. Additionally, besides chlamydia positivity based on biological samples, surveys at baseline (M0), M3, M6 and M12, are used to assess condom use attitude, behavioural capability, self-efficacy, and intention, along with details of any partnered sexual activity and condom use, and health economic data. Nested qualitative interviews with trial participants are used to gain insight into factors affecting recruitment and attrition.
Results: Recruitment to the fRCT began in March 2021 and was completed in October 2021. Data collection is likely to be completed by the end of December 2022.
Conclusions: This feasibility study will provide data to inform the design of a future definitive trial. This work is timely given the rapid rise in the use of internet testing for STIs and the sustained high levels of STIs amongst young people.
Trial Registration: ISRCTN Registry ISRCTN17478654; http://www.isrctn.com/ISRCTN17478654
| Original language | English |
|---|---|
| Journal | JMIR research protocols |
| Publication status | Accepted/In press - 16 Feb 2023 |